Batch Specific Request
A batch specific request is a process by which a drug company (the marketing authorisation holder) can continue to supply a veterinary medicine which otherwise would not be available in Ireland. It applies only in exceptional circumstances where:
- There is an existing the authorised product, for which full manufacturing information is on file with the HPRA,
- The medicine has been shown on testing that it is not in full compliance with all release specifications given in the marketing authorisation,
- The deviation from specification is relatively minor and of a temporary nature,
- The absence of the medicine from the market poses an unacceptable risk to animal welfare.
In this situation, the specified batch-release conditions are temporarily altered to allow a batch of product to be compliant with the dossier on the product.
For further details please refer to the Guide to Batch Specific Requests for Veterinary Medicines which contains additional information about the procedure.
Specific Request applications please complete the Batch Specific Requests Application Form.